United States Patent [19]
`Leonhardt et al.
`
`US005957949A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,957,949
`Sep. 28, 1999
`
`[54] PERCUTANEOUS PLACEMENT VALVE
`STENT
`
`[75] Inventors: Howard J. Leonhardt; Trevor
`Greenan, both of Sunrise, Fla.
`
`Primary Examiner—Michael Powell BuiZ
`Assistant Examiner—Daphna Shai
`Attorney, Agent, or Firm—Paul F. BaWel
`
`[57]
`
`ABSTRACT
`
`[73] Assignee: World Medical Manufacturing Corp.,
`Sunrise, Fla.
`
`[21] Appl. No.1 08/848,892
`[22]
`Filed:
`May 1, 1997
`
`[51] Int. Cl.6 .................................................. .. A61M 29/00
`[52] U.S. Cl. ........................ .. 606/194; 606/108; 606/195;
`606/198; 623/1; 623/2; 623/12
`[58] Field of Search ................................... .. 606/108, 194,
`606/195, 198, 200; 623/1, 2, 12
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3/1988 Palmaz .................................. .. 606/108
`4,733,665
`5,163,953 11/1992 Vince ................. ..
`623/2
`5,411,552
`5/1995 Andersen et al.
`623/2
`5,591,195
`1/1997 Taheri et a1. ........... ..
`606/194
`5,665,103
`9/1997 Lafontaine et al. .
`606/194
`5,667,523
`9/1997 Bynon et al. ......................... .. 606/194
`
`An arti?cial valve stent for maintaining patent one way How
`Within a biological passage is disclosed. The arti?cial valve
`includes a tubular graft having radially compressible annular
`spring portions for biasing proximal and distal ends of the
`graft into conforming ?xed engagement With the interior
`surface of a generally tubular passage. Also disclosed is a
`deployment catheter including an inner catheter having a
`nitinol core Wire, a controllable tip balloon at its the distal
`end for dilation and occlusion of the passage, and a con
`trollable graft balloon in the vicinity of and proximal to the
`tip balloon for ?xedly seating the spring portions in con
`formance With the interior surface of the passage. A spool
`apparatus for adjusting or removing an improperly placed or
`functioning arti?cial valve, and a microembolic ?lter tube
`are usable With the deployment catheter. The arti?cial valve
`may be completely sealed to the living tissue by light
`activated biocompatible tissue adhesive betWeen the outside
`of the tubular graft and the living tissue. A method of
`implanting the arti?cial valve is also disclosed.
`
`17 Claims, 8 Drawing Sheets
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`NORRED EXHIBIT 2099 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00110
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`U.S. Patent
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`Sep.28, 1999
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`Sheet 1 of8
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`1
`PERCUTANEOUS PLACEMENT VALVE
`STENT
`FIELD OF THE INVENTION
`This invention relates to arti?cial valves, speci?cally
`those placed percutaneously by a catheter. The arti?cial
`valve disclosed may replace existing valves such as are in
`the heart or esophagus, or may be placed Where ?uid ?oW
`needs to be maintained in one direction only.
`
`BACKGROUND OF THE INVENTION
`The disclosed invention involves a percutaneously placed
`arti?cial valve to maintain bodily ?uid How in a single
`direction. It opens and closes With pressure and/or ?oW
`changes. The invention may be placed anyWhere ?oW con
`trol is desired. To facilitate the discussion of the disclosure,
`use as a heart valve Will be addressed. Heart valves are
`selected because they provide the highest risk to the patient
`during placement, and in terms of loWering the risk While
`providing a superior device the advantages of this valve are
`clearly presented. It is understood that the device and
`method disclosed are available to all valvular needs.
`Cardiac valve prostheses are Well knoWn in the treatment
`of heart disease. The normal method of implantation
`requires major surgery during Which the patient is placed on
`a heart-lung machine and the patient’s heart is stopped. Once
`the surgery is complete, the patient can expect an extended
`hospital stay and several more Weeks of recuperation. A
`mortality rate of ?ve percent (5%) is common. For some
`patients, surgery is not an option because age or some other
`physical problem prevents them from being able candidates
`for surgery due to the inherent dangers and the likelihood of
`death therefrom.
`The valve devices themselves fall into tWo categories,
`either biological or mechanical. Biological heart valves are
`either homograft (a recent human harvest), allograft (a
`stored human harvest) or xenograft (a stored animal
`harvest). Homografts are rare because of the Well knoWn
`problems of locating and matching human donors in both
`tissue type and siZe. Allografts are also in short supply
`because of lack of donors. Xenografts are common and Well
`accepted, usually from bovine or porcine donors, and many
`times the actual heart valve from the animal is used. These
`devices may be accompanied by immunological rejection
`from the human body When sutured directly to human tissue
`and require the patient to take anti-rejection drugs Which
`suppress the immune system. Generally, the valves are
`treated to reduce the antigenicity of the valve tissue, but the
`effect is to limit the life of the valve to about ten years.
`Mechanical valves may be either a ball valve or a lea?et
`valve having one to three lea?ets. One lea?et valve, US.
`Pat. No. 5,469,868, closely resembles a biological valve
`having three synthetic resin lea?ets. Mechanical valves are
`susceptible to clot formation and require the patient to
`maintain a strict regiment of anticoagulant drugs Which
`carry their oWn associated risks. Furthermore, some
`mechanical valves are prone to Wear leading to failure, and
`some materials for mechanical valves are subject to supply
`problems.
`The majority of these arti?cial valves require surgery and
`the stopping of the heart as discussed above. During
`implantation, the valve must be seWn in place either at the
`natural valve location or at a location adjacent to the natural
`valve. Even neW laproscopic techniques, While substantially
`less invasive, require general anesthesia and a heart-lung
`machine. There are arti?cial valves Which claim to have
`overcome the problems of implantation of the commonly
`used valves.
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`Three arti?cial valves Which claim the ability to be placed
`percutaneously comprise the nearest prior art. They are the
`Tietelbaum valve, US. Pat. No. 5,332,402; the Pavcnik
`valve, U.S. Pat. No. 5,397,351; and the Andersen valve, US.
`Pat. No. 5,411,552. Each of these devices alloW placement
`by minimally invasive techniques. HoWever, each of the
`devices have disadvantages upon Which the disclosed inven
`tion greatly improves.
`The Teitelbaum valve uses nitenol to form each of the tWo
`major elements of the valve. It is a mechanical valve, and as
`such is prone to embolism formation. The tWo types of
`stoppers, a ball and seat and an umbrella and seat, each
`reduce the passageWay diameter through the valve thereby
`reducing the ef?ciency of blood ?oW through the valve, and
`the efficiency of the cardiovascular system itself. Being of
`tWo separate components, the movement adds extra com
`plexity leading to Wear and improper seating. The abun
`dance of metal in direct contact With the tissue requires a
`hydrophilic coating Which may or may not prevent stenosis
`in the valve passageWay. This valve may only be placed in
`the natural valve’s position and not elseWhere in the vascular
`system. Also, the nitenol design proposed requires cooling to
`make it sufficiently compliant to ?t Within the placement
`catheter. Cooled nitenol does not exhibit suf?cient force
`upon Warming and reformation of its intended shape to
`maintain a seal betWeen the stent and the tissue. Lastly, both
`elements must be inserted independently of the other requir
`ing multiple delivery catheters.
`The Pavcnik valve is also a mechanical valve of ball and
`seat design. It utiliZes a Gienturco stent (US. Pat. No.
`4,580,586) capped by a cage to comprise a complex restrain
`ing element for the ball Which is difficult to manufacture.
`The restraining element must be attached to the seat by a
`connecting member to maintain the proper distance betWeen
`the tWo. The ball is made of latex Which can cause a reaction
`With living tissue. The seat is comprised of tWo rings, one
`smaller than the other, displaced from each other by nylon
`mesh. Both the seat and the restraining element are stainless
`steel Which must be fairly stiff and non-compliant to main
`tain suf?cient outWard bias thereby severely restricting the
`natural movement of the cardiovascular system at the point
`of implantation. There are multiple joints Which must be
`soldered together increasing the potential for joint failure
`and breakage. This device requires hooks to maintain
`patency in the tissue, requiring surgery to remove once
`deployed. Repositioning is not possible because of the
`hooks. The balloon must be inserted in a de?ated state and
`?lled after placement Within the cage and seat. The ?lling
`liquid is a silicone rubber Which can have detrimental effects
`on the health of the patient if leaked into the blood stream.
`In Whole, this is a complex design Which is highly suscep
`tible to thrombi emboli and improper function over time.
`The Andersen valve comprises a stainless steel stent to
`secure a biological valve. The stent is formed of tWo or more
`Wavy rings sutured to each other With the top loop requiring
`projecting apices to secure the commissural points of the
`valve. The valve claims reduced Weight but looses this
`advantage by requiring multiple rings to attain patency
`against the tissue. The device requires a special trisection
`balloon With three or more projecting beads to secure the
`valve Within the deployment catheter during placement, and
`the stent does not exert sufficient force against the tissue to
`remain in place Without a balloon expanding the stent tightly
`into the tissue Wall. The stiffness of stainless steel does not
`comply With the natural movement of the cardiovascular
`system Which may lead to stenosis at the implantation point.
`Furthermore, the suture points connecting the multiple rings
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`are subject to movement and Wear against each other and
`therefore the sutures or the rings may break at the connecting
`points.
`One drawback of all three of these valves is that none of
`the devices may be removed or repositioned once they are
`expressed from their placement catheter. Any misplacement
`or failure requires major open heart surgery equal to or
`greater than that noW required by standard procedures. Many
`patients Which receive the valve percutaneously because of
`their intolerance to surgery Would face a very uncertain
`outcome from misplacement or failure. Also, none of these
`devices seal to the living tissue at the outside Wall of the
`prosthesis. Leaks, and therefore emboli, are likely results
`after implantation.
`The need remains for an arti?cial heart valve Which is
`placed percutaneously through a single minimally invasive
`entry point; Which Will seal at the outside Wall of the valve
`With the living tissue of the patient; Which may be placed
`percutaneously at any point as Well as directly over an
`existing vascular or cardiac valve; Which Will not cause
`thrombi emboli to form at the valve thereby removing the
`need for anticoagulant drugs; Which Will comply With the
`natural motion of the tissue to Which it is attached; Which
`Will not cause stenosis; Which does not require general
`anesthesia or stopping the heart or using a heart-lung
`machine during placement; Which Will reduce the recupera
`tion time after placement both in and out of the hospital; and
`Which may be repositioned or removed after placement in
`the event of such a need.
`
`SUMMARY OF THE INVENTION
`
`A percutaneously implanted arti?cial valve maintains
`patent one way How Within a biological passage and
`includes a tubular graft having radially compressible annular
`spring portions for biasing proximal and distal ends of the
`graft into conforming ?xed engagement With the interior
`surface of a generally tubular passage. The graft material is
`attached to and encloses the annular spring preventing
`contact betWeen the spring and living tissue. A valve is
`sealingly and permanently attached to the internal tubular
`portion of the valve graft. The arti?cial valve graft may be
`completely sealed to the living tissue by light activated
`biocompatible tissue adhesive betWeen the outside of the
`tubular graft and the living tissue.
`
`A BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1a is an perspective vieW of the super elastic spring
`stent in its permanent shape prior to attaching the ends to
`form the cylindrical Walls.
`FIG. 1b is an perspective vieW of the super elastic spring
`stent in its permanent shape after attaching the ends to form
`the cylindrical Walls.
`FIG. 1c is a top vieW of the super elastic spring stent in
`its permanent shape after attaching the ends to form the
`cylindrical Walls.
`FIG. 2 is an elevational vieW of the valve stent fully
`deployed Within the mitral valve.
`FIG. 3 is an elevational vieW of the valve stent fully
`deployed Within the aorta above the aortic valve.
`FIG. 4 is a sectional vieW shoWing the biological valve
`Within the stent.
`FIG. 5 is a perspective vieW of the deployment means of
`the present invention.
`FIG. 6 is a sectional vieW thereof taken generally along
`the line 6—6 in FIG. 5.
`
`4
`FIG. 7a is a perspective vieW shoWing a spool apparatus
`and retrieval means of the present invention.
`FIG. 7b is an enlargement of the circled portion Ain FIG.
`7a shoWing the arrangement of a suture loop connecting the
`invention.
`FIG. 8 is an elevational vieW shoWing a micro-embolic
`?lter tube of the present condition in its deployed position.
`FIGS. 9a—9d are a series of elevational vieWs depicting a
`method of deploying the valve stent in the mitral valve
`position.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`FIG. 4 shoWs the preferred embodiment of valve stent 20,
`comprised of three elements. The three elements are stent
`26, biological valve 22, and graft material 24. FIGS. 3, 5,
`7A, and 7B illustrate accessories and options associated
`Which the preferred embodiment, including the deployment
`catheter 100, the bioadhesive material 56 or bioadhesive
`packets 62, the spool apparatus 170, and the microembolic
`?lter tube 182.
`For purposes of the disclosed invention and its
`apparatuses, the distal end is the end ?rst inserted into the
`patient and the proximal end is the end last inserted into the
`patient.
`Stent 26 is shoWn in FIGS. 1a—1c. FIG. 1a shoWs stent 26
`formed of a single piece of super elastic Wire, preferably
`nitenol Wire, With tWo crimping tubes 50. The crimping
`tubes 50 is preferable of the same material as the Wire to
`avoid problems Which occur When dissimilar materials are in
`electrical contact With each other, hoWever other materials
`knoWn in the art may be used. Stent 26 is in its permanent
`shape, although it has not yet had its tWo ends attached to
`itself to form cylindrical Wall 64 (FIG. 1C) Which Will
`support the other elements of valve stent 20. The top and
`bottom portions are substantially symmetrical to each other
`having a Zig-Zag 40 or Wavy form. The preferred embodi
`ment has six (6) Zig-Zags 40 Which optimiZes its compressed
`diameter and outWard force, but more or less may be used.
`At each end of stent 26 is a short extension 58 beginning
`another Zig or Wave. Short extension 58 is to close and attach
`the end to the ?rst Zig or Wave closest to connecting bar 29.
`Short extension 58 and the portion of stent 26 to Which
`crimping tubes 50 enclose are substantially parallel to each
`other to facilitate their connection.
`The connection is achieved through a crimping tube 50 as
`shoWn in FIG. lb, or by permanent adhesives or Welding
`Which are not shoWn. As is seen in FIG. 1c, the crimped
`connection is made such that the short extension 58 falls
`substantially Within the area of cylinder Wall 64 formed
`When the connection is complete.
`FIG. 1b shoWs stent 26 in its completed form With
`crimping tubes 50 crimped. This form creates an imaginary
`cylinder 48 Which Will exert an approximate outWard force
`of 350 grams or more at each end. An outWard force of 350
`grams at the mitral valve position is suf?cient to secure the
`valve stent, hoWever stent 26 may be manufactured With
`more or less outWard force to accommodate other placement
`positions. The super elasticity of the material alloWs it to
`deform to forces exerted on it only at those points experi
`encing the deforming force. All other points Will seek their
`permanent shape. This alloWs stent 26 to conform to and seal
`against the dramatically different structures occurring Within
`vessel Walls and valve locations With one basic stent shape.
`Stent 26 is a continuous super elastic nitenol Wire having
`a distal end and a proximal end. Both the distal end and the
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`proximal end are substantially identical, both forming a
`cylinder Wall 64 of six Zig-Zags 40 or Waves. Each end is
`pre-siZed in diameter to be approximately thirty percent
`(30%) larger in diameter than the largest diameter of the
`tissue against Which the valve stent 20 (FIG. 3) Will seal. The
`overall length of stent 26 is also pre-siZed to be suf?cient to
`maintain patency against ?uid ?oW in the vessel or natural
`valve position, as Well as completely support the biological
`valve (or mechanical or synthetic valve) Without causing
`valve 22 to suffer prolapse or insuf?ciency.
`The nitinol Wire used to form stent 26 is a super elastic
`straight annealed material formed substantially of titanium
`and nickel. It may be coated With a biocompatible material,
`such as titanium oxide, Which Will reduce the tissue’s
`reaction to the nickel and improve radiopacity. A layer of
`PTFE may also cover stent 26 to reduce the risk of blood
`clotting and corrosion. Furthermore, stent 26 may be treated
`With iridium 192 or other loW dose Beta radiation emitting
`material to reduce post-surgical cell proliferation in the
`vessel or valve position. Valve stent 20 may have radio
`opaque markers in predetermined positions to aid in deploy
`ment and placement.
`Each Zig-Zag 40 or Wave is equidistant from the next in its
`set and all are of the same height. The peaks and valleys
`forming the Waves are all of a predetermined radius to
`maximiZe the spring bias and prevent sharp transitions
`Which create Weak points in stent 26. Once crimped, stent 26
`forms tWo cylinders, one at each end of stent 26. Each
`cylinder is substantially directly above or beloW the other
`cylinder.
`The cylinders are spaced a predetermined distance from
`each other by a connecting bar 29 Which is the central part
`of the continuous Wire from Which stent 26 is formed.
`Connecting bar 29 is also biased outWard to conform to the
`living tissue so as to minimally disrupt blood or other ?uid
`?oW, thereby minimiZing the possibility of clotting. It is also
`covered by and sutured to graft material 24 (FIG. 4).
`Connecting bar 29 provides torsional stability for valve stent
`20.
`FIG. 2 presents a complete pre-siZed valve stent 20 fully
`deployed in the location of mitral valve 14. Also refer to
`FIG. 4 to identify elements in the folloWing discussion.
`Mitral valve 14 has been prepared for deployment by
`valvuloplasty to remove plaque and ?stulas if necessary.
`Valve stent 20 comprises a malleable graft material 24
`enclosing deformable self-expanding stent 26 to Which a
`biological valve 22 is attached. Stent 26 biases the proximal
`and distal ends of valve stent 20 into conforming and
`sealingly ?xed engagement With the tissue of mitral valve
`14. The deployed valve stent 20 creates a patent one Way
`?uid passageWay.
`Graft material 24 is a thin-Walled biocompatible, ?exible
`and expandable, loW-porosity Woven fabric, such as poly
`ester or PTFE. It is capable of substantially conforming to
`the surface of the living tissue to Which stent 26 coerces it.
`Graft material 24, through its loW porosity, creates the
`one-Way ?uid passage When sutured to the cylindrical form
`of stent 26. The middle portion of graft material 24 is tapered
`to a smaller cross-sectional area than its ends to prevent
`bunching of the material once placed Within the patient.
`Stent 26 is sutured Within graft material 24 using poly
`ester suture 60. Prior to seWing, graft material 24 is arranged
`to surround stent 26 and is heat pressed to conform to the
`distal and proximal cylindrical ends of stent 26 using an
`arcuate press surface (not shoWn). The arcuate press surface
`is heated to 150 degrees Fahrenheit and corresponds in
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`curvature to the distal and proximal ends. A preferred
`stitching pattern involves tWo generally parallel stitches, one
`on each side of the Wire, and a cross-over stitch (not shoWn)
`around the Wire for pulling the stitches together. This
`achieves tight attachment of graft material 24 to stent 26
`thereby preventing substantially all contact betWeen stent 26
`and living tissue. The stitching also Will be reliable over the
`life of the patient.
`Where other vessels or passages leave the vessel receiving
`valve stent 20 at a placement site, or When valve stent 20
`must ?air at one or both ends as is shoWn in FIG. 2, graft
`material 24 may be cut out betWeen the plurality of disten
`sible ?ngers 46 formed by Zig-Zags 40 of stent 26. Disten
`sible ?ngers 46 form a conical tip When compressed together
`Which facilitates loading valve stent 20 in the deployment
`catheter (FIG. 5) prior to the procedure and if retrieval after
`deployment is necessary. Valve stent 20 may be placed such
`that other vessels are not blocked by placing distensible
`?ngers 46 on either side of the vessel junction. Stent 26 is
`pre-siZed to open beyond the Width of the natural valve
`mouth and Will ?air suf?ciently to conform and seal to the
`tissue.
`Biological valve 22 is preferably a porcine valve treated
`and prepared for use in a human. It has tWo or more
`commissural points 68 as is seen in FIG. 4. Biological valve
`22 is attached to stent 26, to graft material 24, or both With
`sutures 60 or biocompatible adhesive or a combination of
`the tWo. Biological valve 22 is pre-siZed to ?t Within the
`internal diameter of cylinder 48 formed by stent 26 attached
`to graft material 24. Attachment is along biological valve’s
`22 commissural points 68 and around its base. Whereas a
`biological valve is preferred, a mechanical valve or a syn
`thetic lea?et valve may also be employed.
`A preferred deployment catheter 100 is illustrated in
`FIGS. 5 and 6. Deployment catheter 100 is generally long
`and tubular permitting percutaneous delivery of valve stent
`20 to the placement site. Deployment catheter 100 has a
`proximal end remaining outside of the patient and a distal
`end Which is inserted into the patient. The proximal end
`alloWs access to a plurality of lumens, syringes, ?lter tube
`182, spool apparatus 170, and other apparatus as necessary
`for implantation of the disclosed invention. Outer sheath 106
`has an axially extending sheath passage 108 and receives an
`elongated compression spring push rod 112 Within sheath
`passage 108. A push rod 112 also has a passage extending
`through its longitudinal axis created by the spring coils.
`Inner catheter 110 is slidably mounted Within push rod 112
`passage.
`Outer sheath 106 is made of a loW friction and ?exible
`material, preferably PTFE. Other suitable materials such as
`polyurethane, silicone, polyethylene may be used instead of
`PTFE. The material is preferably clear to alloW inspection of
`valve stent 20 and deployment catheter 100 prior to use.
`The siZe of outer sheath 106 depends on the siZe of valve
`stent 20 to be implanted. Common siZes range from 12 FR
`to 20 FR. Collapsing distensible ?ngers 46 of valve stent 20
`together forms a conical tip Which alloWs for easy loading by
`sliding outer sheath 106 over the tip and on until valve stent
`20 resides Within outer sheath 106 and beyond by approxi
`mately ?ve millimeters. The conical tips alloW a reduction in
`the pro?le of valve stent 20 of 2 FR, Which alloWs a smaller
`diameter outer sheath 106 to be used. This results in a
`smaller entry incision and less trauma to the patient’s access
`passageWay.
`Outer sheath 106 has a side port means 116 near its
`proximal end. Side port means 116 provides access for
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`transporting ?uid, such as heparin or contrast dye, through
`outer sheath 106 passage and into the patient. Side port
`means 116 includes a manually operated valve in ?uid
`communication With outer sheath 106 passage through a
`?exible tube adapted to receive suitable ?uid injection
`means (not shoWn). Proximal to side port means 116, outer
`sheath 106 has at least one latex-lined homeostasis valve
`(not shoWn) for forming a ?uid seal around push rod 112 to
`prevent blood or other ?uid from leaking out of the delivery
`catheter at the proximal end.
`Biological valve 22 should be in an open position When
`valve stent 20 is loaded into outer sheath 106. This reduces
`overall pro?le and stress on biological valve 22 and its
`attachment to stent 26 and cover material. An open valve 22
`also alloWs inner catheter 110 to pass through valve 22 prior
`to and during deployment With negligible chance of damage
`to the valve 22. Valve stent 20 is loaded either end ?rst into
`outer sheath 106, the correct choice depending upon the
`access path taken and the ?uid ?oW direction at the place
`ment site. After placement, biological valve 22 should open
`in the direction of blood ?oW.
`Inner catheter 110 is longer than either outer sheath 106
`or push rod 112 permitting it to extend beyond outer sheath
`106 and push rod 112 at both ends. Inner catheter 110 may
`be made of 8 FR catheter tubing. As is seen in FIG. 6, inner
`catheter 110 comprises an embedded, kink resistant nitinol
`core Wire 122, a ?rst inner track 124, a second inner track
`126, and a third inner track 128, all extending lengthWise
`thereof. Referring to FIG. 5, a ?rst end port means 130 for
`transporting ?uid to ?rst inner track 124 includes a threaded
`adapter 132 for mating With suitable ?uid injection means
`(not shoWn) and communicating With a proximal end of ?rst
`inner track 124 through a ?exible tube. A second end port
`means 136 for transporting ?uid to second inner track 126
`includes a manually operable valve communicating With the
`proximal end of second inner track 126 through a ?exible
`tube and adapted to receive a suitable ?uid injection means.
`Similarly, a third end port means for transporting ?uid to
`third inner track 128 includes a manually operable valve
`communicating With a proximal end of third inner track 128
`through a ?exible tube and adapted to receive a suitable ?uid
`injection means.
`Apreferred option of core Wire 122 is a gradual tapering
`from a diameter of approximately 0.031 inches at its proxi
`mal end to a diameter of approximately 0.020 inches at its
`distal end, With the distal tip of core Wire 122 being rounded
`and smooth. This feature provides that the proximal end of
`inner catheter 110 is strong and the distal end of inner
`catheter 110 is less likely to puncture or rupture the access
`passage yet Will not de?ect signi?cantly under the force of
`blood ?oW. Additional to being kink resistant and strong,
`core Wire 122 displays superior torsional rigidity translating
`into substantial rotational equivalence along the entire
`length of core Wire 122 When turning inner catheter 110 in
`either direction at the proximal end.
`Second inner track 126 and third inner track 128 com
`municate With balloons at the distal end of inner catheter
`110. Second inner track 126 alloWs ?lling and emptying tip
`balloon 152 and third inner track 128 alloWs ?lling and
`emptying expansion balloon 154. Expansion balloon 154 is
`larger in diameter and shaped according to the placement
`site Tip balloon 152 is essentially round and of necessary
`diameter to block blood ?oW to the placement site if needed.
`Balloons are preferably polyurethane and act in a calibrated
`pressure compliant manner such that injecting a knoWn
`amount of ?ll ?uid into balloons relates to a knoWn expan
`sion in the diameter of balloons. Also, WithdraWing a known
`
`10
`
`15
`
`25
`
`35
`
`45
`
`55
`
`65
`
`8
`amount of ?ll ?uid from balloons relates to a knoWn
`contraction in the diameter of balloons. Fill ?uid is prefer
`able ?ltered carbon dioxide because of it radiopacity. Fill
`?uid is injected into second inner track 126 and third inner
`track 128 by separate ?uid injection means, respectively.
`Fluid injection means may comprise a transparent volume
`marked syringe With slidable plungers for observably con
`trolling the plenum volume of the syringe ?lling or emptying
`a balloon.
`Tapered head 156 resides betWeen tip balloon 152 and
`expansion balloon 154. It alloWs a calm and smooth atrau
`matic transition from the pro?le of inner catheter 110 to the
`pro?le of outer sheath 106 or to the pro?le of microembolic
`?lter tube 182 (FIG. 8). Tapered head 156 preferably de?nes
`a ?rst annular abutment lip 158 arranged to engage the distal
`end of outer sheath 106 Which prevents tapered head 156
`from entering outer sheath 106 passage. Tapered head 156
`may contain a second abutment lip (not shoWn) of slightly
`larger diameter than ?rst abutment lip 158 or a ?air from a
`smaller to a larger diameter beginning at the ?rst abutment
`lip 158 for preventing the advancement of the distal end of
`microembolic ?lter tube 182 When it is being employed.
`Push rod 112 is a metallic compression spring having a
`combination of ?exibility and axial compression strength to
`enable it to folloW a tortuous path Without loosing its ability
`to act as a push rod for exerting force against valve stent 20
`during deployment. Push rod 112 is smaller in diameter than
`outer sheath 106 such that both are independently slidable
`relative to the other. Push rod 112 has an internal path larger
`in diameter than inner catheter 110 such that both are
`independently slidable relative to the other. The distal end of
`push rod 112 de?nes a plunging seal 162 for stopping ?uid
`?oW into the deployment catheter 100 proximal to plunging
`seal 162. If spool apparatus 170 (FIG. 7a) is employed,
`either plunging seal 162 must be left out, or suture loops 174
`must pass through the opening inner catheter 110 passes
`through, or one of the lumens or an extra lumen provides
`passage for suture loops 174. Push rod 112 may also include
`damping means (not shoWn) near its distal end, such as a thin
`heat-shrunken polyoli?n or polyimid coating, Which damp
`ens undesirable recoil of push rod 112.
`Valve stent 20 has several preferred options. One is light
`activated bioadhesive material 56 on the outside of graft
`material 24 shoWn in FIG. 2. Bioadhesive material 56
`remains inert and Will not bind until it is exposed to light
`Waves of a speci?c frequency. Bioadhesive 56 Will not react
`to sunlight or to standard bulbs found at home or in the
`operating room. Once deployment is complete and position
`ing and function veri?ed, a light source (not shoWn) is
`inserted and energiZe. The source emits light of the proper
`frequency such that When bioadhesive 56 is exposed to the
`light it sets, binding valve stent 20 to the living tissue and
`sealing any small microleaks.
`Another variation is bioadhesive material 56 Which is
`contained in photosensitive polyurethane packets 62 as
`shoWn in FIG. 3, Which degrade and release the adhesive
`When exposed to light of the proper frequency. Packets 62
`are af?xed to the outside of graft material 24 Which Will
`contact the living tissue. Again, once valve stent 20 is
`positioned and functioning, a light source is inserted and
`energiZed. Packets 62 then